Outlook® 621-400ESRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964186554), received between Mar 28, 2017 and May 6, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2021Temperature Problem; Temperature Problem

  AS PER REPORTED BY THE USER FACILITY: PUMP BEGAN TO SMOKE AND THERE WAS BLACK CHARRING AROUND THE OUTLET. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782831 ↗
• MalfunctionOct 27, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED ON MEDWATCH (B)(4): PATIENT WAS ORDERED AN INFUSION OF D10, TOTAL OF A 321.5 ML BOLUS. THE PUMP WAS FOUND TO HAVE INFUSED 500 ML, OVERINFUSING THE PATIENT BY 178.5 ML EXTRA D10. THE PATIENT SUFFERED NO HARM BUT REQUIRED ADDITIONAL MONITORING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6984845 ↗
• MalfunctionMar 28, 2017Temperature Problem; Temperature Problem

  AS REPORTED BY CUSTOMER: ON (B)(6) 2017 AT APPROXIMATELY 4:30 AM - PATIENT AND HUSBAND WERE IN THEIR ROOM WHEN ROOM STARTED TO FILL WITH SMOKE. THEY CALLED FOR RN AND THE RN NOTICED THAT IT WAS ORIGINATING FROM THE PUMP. NORMAL SALINE WAS RUNNING. PATIENT AND HUSBAND WERE MOVED TO ANOTHER ROOM. ALL VITALS WERE STABLE, NO VISIBLE HARM, PATIENT WAS ANXIOUS. TUBING WAS MOVED TO A DIFFERENT PUMP. PUMPS WERE TAKEN TO BIOMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439545 ↗
• MalfunctionMar 28, 2017Temperature Problem; Temperature Problem

  AS REPORTED BY CUSTOMER: ON (B)(6) 2017 AT APPROXIMATELY 4:30 AM - PATIENT AND HUSBAND WERE IN THEIR ROOM WHEN ROOM STARTED TO FILL WITH SMOKE. THEY CALLED FOR RN AND THE RN NOTICED THAT IT WAS ORIGINATING FROM THE PUMP. NORMAL SALINE WAS RUNNING. PATIENT AND HUSBAND WERE MOVED TO ANOTHER ROOM. ALL VITALS WERE STABLE, NO VISIBLE HARM, PATIENT WAS ANXIOUS. TUBING WAS MOVED TO A DIFFERENT PUMP. PUMPS WERE TAKEN TO BIOMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439543 ↗